RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.

About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

New: Take the RAC Exam Online

The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move
across top level links and expand / close menus in sub levels. Up and Down arrows will open main level
menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab
will move on to the next part of the site rather than go through menu items.

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

The RAPS store will be under maintenance Saturday, 13 June between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

The European Parliament's (EP) Committee on the Environment, Public Health and Food Safety (ENVI) has endorsed and released a new draft rule regarding clinical trials for new medicines, saying the changes should result in "simpler, more uniform" rules and halt a five-year decline in clinical trials being conducted in the EU region.

Background

The rule was first called for in July 2012 by then-health commissioner John Dalli, who pointed to the 25% decline in EU clinical trials. The reason, he said, was mostly attributable to the difficulties associated with conducting trials in the EU under the Clinical Trials Directive (2001/20/EC), which Dalli said was "arguably the most heavily criticized piece of EU legislation in the area of pharmaceuticals."

Dalli said an ideal proposal would include faster assessment procedures, reporting mechanisms, timelines for approval and trial extensions, mechanisms for all of which were included in a framework proposal he put forth in July 2012.

Then, in February 2013, ENVI announced the release of an amended version of Dalli's original proposal, which called for full publication of all clinical trials data. "Clinical trial data should not be considered commercially confidential once a marketing authorisation has been obtained," legislators wrote. "For the sake of transparency, once a clinical trial has led to marketing authorisation, data generated during the clinical trial should be fully accessible."

Legislators also proposed requiring companies to generate standardized clinical study reports (CSRs) using International Conference on Harmonisation (ICH) guidelines (ICH E3). "The introduction of the clinical study report is in the interest of increased transparency," legislators explained. "These are internationally accepted guidelines on preparing a full description of a clinical trial and its results.&nbsp; This will help sponsors provide harmonised information, and increase transparency by greatly increasing the amount of data available to the public and independent researchers."

New Developments

Now ENVI legislators have announced the release of the most recent iteration of the proposal, which have now won the endorsement of the Public Health Committee. The revisions are meant to replace the Clinical Trials Directive, the legislators wrote.

"The aims of the Directive were admirable, but many of the requirements were geared towards trials sponsored by pharmaceutical companies, while those with non-commercial sponsors were overlooked, and true harmonisation was never achieved," said Glenis Willmott (UK), a member of parliament. "Getting better legislation in place soon is crucial to enable and encourage life-saving research."

The transparency measures appear to have made their way into the most recent draft, with legislators explaining that "detailed summaries" must be made available in an accessible EU database prior to a drug's approval, and full Clinical Study Reports (CSRs) made available after market authorization is received. Fines would be assessed on companies that fail to comply.

In other areas, legislators said the revisions would reduce the burdens for providing compensation for damages, which would instead be covered by the national healthcare systems of each respective country. For other trials, countries could set up indemnification systems to reduce the insurance costs for the trial sponsor. The overall intent is to decrease the costs of many trials.

The changes, which are visible here, will still need to be approved by the full European Parliament, which would occur at its October 2013 Plenary session, and then by the Council of the European Union.